Strengthening our global leadership in treatment of addiction. JP Morgan Healthcare Conference January 11, 2018

Transcription

1 Strengthening our global leadership in treatment of addiction JP Morgan Healthcare Conference January 11, 2018

2 Forward Looking Statements This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forwardlooking statements include, among other things, statements regarding the Indivior Group s financial guidance for 2017 and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation. Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group s products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group s drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group s products and product candidates; risks related to legal proceedings, including the investigative and antitrust litigation matters; the Indivior Group s ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group s products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items. 2

3 OUR VISION For all patients around the world to have access to evidenced-based treatment for the chronic relapsing condition and cooccurring disorders of addiction

4 Why Invest in Indivior? 1. Targeting a global epidemic addiction and its co-occurrences 2. Building on leading Buprenorphine Medication-Assisted Treatment (BMAT) position to develop and commercialize novel, break-through addiction treatments 3. Generating strong profitability and cash flow today with potential upside from new products and continued pipeline success 4

5 Addiction The scale of the problem

6 Treating Addiction is our Primary Focus Addiction affects millions globally (2) 29 mil. people aged 15 to 64 suffer from drug use disorders or drug dependence (1) 3.6 mil. years of life were lost due to premature death caused by drug use in 2010 (2) 55% of the lost years were due to premature death caused by opioid dependence (2) (3) 124 mil. people globally dependent on alcohol (3) 3 mil. deaths caused by harmful alcohol use annually (3) (1) United Nations Office on Drugs and Crime, World Drug Report 2016 (2) L. Degenhardt and others, Global burden of disease attributable to illicit drug use and dependence: findings from The Global Burden of Disease Study 2010 The Lancet 2013 (3) World Health Organization (WHO) Global Status Report on Alcohol and Health

7 US Life Expectancy Opioid Use Disorder (OUD) is an Epidemic in the US and is Accelerating * Age-adjusted drug overdose death rates by opioid category (US 1999 to 2016) 21% 2x The increase in overdose deaths to 63,632 lives in 2016 vs. 52,404 lives in 2015 ** The rate of increase in deaths from synthetic opioids like fentanyl vs ** *Source: Center for Disease Control and Prevention and National Center for Health Statistics, Drug Overdose Deaths in the United States, December 2017 ( **Source: Financial Times ( (1) Significant increasing trend from 1999 to 2016 with different rates of increase over time, p<0.05 (2) Significant increasing trend from 1999 to 2006, then decreasing from 2006 to 2016, p< & 2015 declines largely due to drug overdoses, and follow over a decade of increases ** 7

8 The US Recognizes OUD as a Legitimate Disease Large Market (1) (2) 80% of world s opioid users 300MM pain prescriptions written in 2015 worth $24bn Conducive Intervention Policy (3) Growing awareness of epidemic with increased government focus declared as a nationwide public health emergency Medication-assisted treatment (MAT) endorsed by US government CARA legislation and CURES Act increased addiction resources Growing Treatment Capacity (4) Patient cap raised to 275 from 100; NP and PAs able to prescribe with training Record physician certifications in 2016, continued into 2017 (1) December 9, 2014 Express Scripts report titled, America s Pain Points, (2) (3) (4) CARA legislation expands treatment availability; DEA report of waivered HCPs December

9 Core US Market Growth Remains Strong as Treatment Capacity Continues to Grow in Response to Epidemic Strong, consistent market expansion - Total buprenorphine market in mg (1) (millions) - Driven by growing treatment capacity - No. of HCP certifications (cumulative certifications in thousands) - 5 Yr. CAGR: 10.2% 20% Compounded Annual Growth Rate Source: Symphony Health Retail and Non-Retail Sales data (1) Market MG volume in derived from New IDV Source: NTIS DEA Certifications; Internal estimates *Estimated waivered HCP number 9

10 Indivior s Leadership Position US Addiction

11 Developing Innovative Treatments for OUD for Decades Mono dose form Combination form Combination form ATRIGEL delivery system Buprenorphine only Sublingual tablet Buprenorphine plus Naloxone Sublingual tablet Fast-dissolving film Improved patient tolerance Once monthly subcutaneous injection SUBUTEX SUBOXONE SUBOXONE Film SUBLOCADE Injection Future Franchise 11

12 Strong Track Record of Growth and Profitability in Addiction; Revenue and Profit Growth have Recently been Restored SUBOXONE launched in US Generic bup/nal tablets launched ($ in mil.) Branded competitors launched CURES & CARA Legislation $1.05 bil. (+4% vs. 2015) Net revenue $387 mil. (+3% vs. 2015) Adj. operating profit Adj. FY2015 Op. profit: (1) Excludes $31 mil. related to separation costs and impairments and write-offs. Adj. FY2016 Op. profit: (1) Excludes $11 mil. write off of manufacturing costs related to potential negative ANDA outcome. (2) Excludes $7 mil. exceptional items related to costs for ANDA strategic planning. (3) Excludes $220 mil. provision for investigative and antitrust matters. 12

13 Generic bup/nal tablets launched Zubsolv tablet launched CVS formulary loss United formulary loss and 3rd generic tablet approved BUNAVAIL launch CVS formulary change CareSource MM loss US SUBOXONE Film Share has been Resilient *Please Note: Share values might not foot due to rounding. 13 Source: Symphony Health, Retail PHAST Weekly Prescription Data ending September 29 th

14 Well-Positioned to Address the US OUD Epidemic and Generate Long-term Profitable Growth Daily Film Monthly Depot Treatments that deliver on unmet patient needs Complementary options for physicians and patients In concert with psychosocial support > 2.5mil. < 50% patients diagnosed with OUD in the US (1) of diagnosed patients receive any MAT (1) (1) Volkow ND, Frieden TR, Hyde PS, Cha SS Medication-assisted therapies-tackling the opioid-overdose epidemic. N Engl J Med 370(22): doi: /NEJMp

15 SUBLOCADE (buprenorphine extended release) Injection A New Treatment for Moderate-to-Severe Opioid Use Disorder (OUD) What: The first and only once-monthly buprenorphine depot injection delivery system Where: US, initially When: Mid-Q launch Status: Approved by FDA November 30 th Dosage: 100mg and 300mg 15

16 SUBLOCADE Injection: A Key & New Asset for Treatment of Moderate to Severe OUD SUBLOCADE is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program Sustained Medication Delivery Sustained plasma levels of buprenorphine that translate into high µ-opioid receptor occupancy to block the subjective and objective effects of illicit opioid drugs Shown superior to placebo in achieving more illicit opioid-free weeks (p<0.0001) Achieved complete blockade of drug-liking effects for a full month in most patients Treatment Compliance Once-monthly SUBLOCADE removes the need to patients to remember to take their medication every day Monthly decisions (12/year) rather than daily decisions (365/year) Known Safety Profile Adverse event profile comparable to SL buprenorphine, except for injection site reactions SUBLOCADE will be distributed through a restricted distribution system, which is intended to prevent the direct dispensing to the patient 16

17 Working Alongside Payers to Provide Patient Access & Support Payer Coverage Consulting with Payer Groups Aligned on burden of disease Firm understanding of unmet needs Targeting robust formulary coverage in 2018 Medical benefit Complements overall patient treatment program, including psychosocial support Patient Access $5 Copay Program for eligible patients Patient Support INSUPPORT TM is Indivior s patient support platform providing services to help facilitate unrestricted access to treatment PROVIDER LOCATOR FIELD REIMBURSEMENT SERVICES (FRS) COPAY ASSISTANCE HUB SERVICES 17

18 RBP-7000 Targeting unmet needs in schizophrenia

19 RBP-7000 for Schizophrenia Unmet Patient Needs 23mil. 76% People worldwide affected by schizophrenia (1) of patients initiated on long-acting injectables have concurrent oral supplementation (2) RBP-7000 Treatment What: Where: U.S. Status: Investigational Once monthly Risperidone in ATRIGEL NDA Accepted PDUFA Date = July 28, 2018 (1) Schizophrenia in table on page 1567 (2) Doshi JA et al. J Clin. Psychopharmacol. 2015, 35:

20 RBP-7000 Objective: Address What We Believe the Current Unmet Needs are in Long Acting Antipsychotics Rapid onset 1 Extended treatment duration 2 Manageable tolerability 3 No oral co-medication 4 Measurable quality of life benefits 5 20

21 RBP-7000: Indivior s Next Commercial Growth Opportunity Why It s Attractive: First commercial expansion outside addiction Demonstrates agility and diversification aligned with growth strategy US antipsychotic LAI market growth is attractive: 20%+ growth over last 5 years (1) LAI share of total US antipsychotic market has grown from 4.1% in 2010 to 12.7% in 2015 (1) Schizophrenia is understood by payers as a disease area requiring vigilant management Leverages Existing Capabilities: Underserved/stigmatized patient population Known unmet patient needs related to PK Specialty product Known molecule Consistent pharmacokinetic profile ATRIGEL technology (1) Source: IMS 21

22 R&D Focus

23 R&D Efforts Focused on Strengthening Leadership Profile in Addiction SUBLOCADE Leadership Evidence Generation & Optimization (LEGO) RECOVER Study assess the effects of SUBLOCADE on health-related quality of life (HRQoL) in real world setting Emergency Room Study assess the efficacy and safety of initiating SUBLOCADE in the ER to potentially prevent repeat overdose events in OUD patients VAS Craving Study validate VAS scale to assess cravings in patients with OUD Buprenorphine Abuse, Misuse, Diversion (AMD) Epidemiology understand root causes of buprenorphine abuse, misuse and diversion Addex Therapeutics GABA B PAM Collaboration GABA B receptor pathway has been identified as a highly attractive target to potentially treat various addiction disorders (1) Lead compound (ADX71441) demonstrated efficacy in animal models for alcohol use disorder (AUD) (2) ADX program awarded $5.3 million grant from NIDA to support human studies for cocaine abuse disorder (CUD) (3) Exclusive global rights to backup GABA B compounds and additional compounds discovered through joint research efforts Arbaclofen Placarbil for Alcohol Use Disorder Reformulation and clinical pharmacology assessment ongoing Addex collaboration will complement current discovery efforts (1) Phillips & Reed Targeting GABAB receptors for anti-abuse drug discovery. Expert Opin Drug Discov. 9(11): (2) Augier et al.: The GABAB positive allosteric modulator, ADX71441 attenuates alcohol self-administration and relapse to alcohol seeking in rats, Neuropsychopharmacology, 2017, Mar 15 - Epub ahead of print (3) 23

24 DELIVERING ON OUR PRIORITIES

25 9 Mos. Year to Date 2017 Highlights Financial Highlights (1) (In $mil., except EPS) 2017 Y/Y (Δ%) Net Revenue $828 +4% Operating Profit $333 +6% Net Income $216 +5% EPS (fully-diluted) 30 cents +7% Net Cash (vs. FY2016) $ % Guidance for FY 17 Reconfirmed: - Net Revenue $1,090 to $1,120 - Net Income $265 to $285 No material changes to current market conditions Excluding exceptional items and at constant FX Includes $40 mil. to $60 mil. of pre-launch investments for late stage pipeline assets (1) 9 Mos. Year-to-Date 2017 Results Announcement published November 2nd, 2017 on an Adjusted Basis, excluding $25 mil. of effects of exceptional items related to the Amneal settlement 25

26 Delivering on Our Priorities has Created Greater Certainty SUBOXONE Film Resilience End 2017 with leading share among daily BMAT options Pipeline Progress SUBLOCADE approved by FDA and RBP-7000 NDA accepted by FDA with Q PDUFA date; New Addex Therapeutics GABA B collaboration Expand Treatment Access Record physician certifications; Nurse practitioner and physician assistant certifications ahead of expectations Assert Intellectual Property remain confident in ANDA litigation, asserting new 454 Orange Book listed patent issued in June 2017 Grow Financial Strength Record cash balance, improved and extended debt terms 26

27 Summary We face the future with confidence We are making progress in managing the risks to the business We look forward to continuing our progress to create shareholder value 27

28 THANK YOU.

29 IMPORTANT SAFETY INFORMATION Indication SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of healthcare providers qualified under the Drug Addiction Treatment Act. Important Safety Information Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported. SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit. SUBOXONE Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine. SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film. You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death. Death has been reported in those who are not opioid dependent. Your healthcare provider may monitor liver function before and during treatment. SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone. Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death. Do not take SUBOXONE Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms. Injecting the SUBOXONE Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings. Before taking SUBOXONE Film, tell your healthcare provider if you are pregnant or plan to become pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your healthcare provider immediately and you should report it using the contact information provided below. * Opioid dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly. Before taking SUBOXONE Film, talk to your healthcare provider if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE Film can pass into your breast milk. You and your healthcare provider should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can cause drowsiness and slow reaction times during dose-adjustment periods. Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness. This is not a complete list of potential adverse events associated with SUBOXONE Film. Please see full Prescribing Information for a complete list. *To report pregnancy or side effects associated with taking SUBOXONE Film, please call You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA For more information about SUBOXONE Film, SUBOXONE (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at 29

30 INDICATION AND USAGE SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by a dose adjustment period for a minimum of seven days. SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support. WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. IMPORTANT SAFETY INFORMATION Prescription use of this product is limited under the Drug Addiction Treatment Act. CONTRAINDICATIONS SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL delivery system WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in 5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. 30

31 APPENDIX

32 Indivior PLC (LON: INDV) Snapshot 2016 Operating Highlights (1) $1.05 bil. (+4% vs. 2015) Net revenue $387 mil. (37% margin) Adj. operating profit (3) $692 mil. Cash balance 40 19% Europe Countries of presence 965 Employees worldwide 2016 Sales by Geography (2) 19% ROW $1.05 bil. 81% U.S. (1) Indivior 2016 Annual Report inside cover, pgs. 4, 36 (2) FY 2016 press release, pg. 19 (3) Adjusted basis, excluding the impact of exceptional SD&A items of $2 million in Q4 and $238 million in the full year 32

33 Ex-US Markets in Earlier Stage of Development 2016 Sales by Geography (2) 19% ROW $1.05 bil. EU (>1 mil. problem opioid users) differs from US as opioiddependence mainly heroin addiction (1) Policy focused more on harm reduction for society than on patient recovery Methadone clinics, strict supervision prevail Volume growing slowly, value in decline due to austerity pressures Scope to grow by building recognition of painkiller dependence (estimated up to 0.45 mil. patients) ROW (~23 mil. people with drug use disorders) opioid drug use almost exclusively heroin addiction (1) Under-developed or adversarial policy regimes (penal sentences for possession) in many countries China is the largest potential market (~7 mil. opioid dependent including 1.4 mil. registered drug users) Australia is a well developed market based on US model Scope for growth in ex-us markets in the medium to long-term (1) 2015 World Drug Report. European Drug Report 2015 (EMCDDA): China Narcotics Control Report, , NNCC Office Drug use and dependence from World Drug Report refers to opiates, cocaine, cannabis, amphetamines, and psychoactive substances -Indivior PLC annual report 2015 p.13. Full details of sources on p.137 (2) FY 2016 press release, pg

34 INDIVIOR PIPELINE

35 Key Pipeline Assets Have Sales Potential of >$2 billion Stage of Development Status (1) Buprenorphine Lifecycle Phase 1 Phase II Phase III NDA Efficacy Safety Launch Peak Net Rev. Forecast (2) SUBLOCADE Injection Approved Q1 18 Launch Ph. III Ph. III Achieved primary & secondary endpoints Q $1 bil. Schizophrenia Phase 1 Phase II Phase III NDA Efficacy Safety Launch Peak Net Rev. Forecast (2) RBP-7000 Accepted Q3 18 PDUFA Ph. III Ph. III Achieved primary & secondary endpoints Q $200 to $300 mil. Alcohol Use Disorder Phase 1 Phase II Phase III NDA Efficacy Safety Launch Peak Net Rev. Forecast (2) Arbaclofen Placarbil Fast Track Designation 5/23/16 Completed Phase 1 Bioavailability Study; Study data under review $500 to $900 mil. Addiction Phase 1 Phase II Phase III NDA Efficacy Safety Launch Peak Net Rev. Forecast ADX71441 Expected to enter Phase 1 trials in 2018 (1) Dates are best estimates only and subject to change (2) Q4 FY 2017 Results Press Release Published February 22 nd, 2017, Pg. 184; Investor Day presentation, November 21 st

36 LITIGATION

37 Major Litigation The Group carries a provision of $217m for the investigative and antitrust litigation matters noted below. The provision was reduced by $25m compared to period ending Q2 2017, reflecting payment of previously reserved settlement amount to Amneal Pharmaceuticals LLC (Amneal). Other than reducing by the Amneal settlement amount, the Group has not changed the previously recorded provision, as the other litigation and investigations are ongoing. The Group continues in discussions with the Department of Justice about a possible resolution to its investigation. The Group cannot predict with any certainty whether it will reach an ultimate resolution with the Department of Justice or any or all of the other parties, or the ultimate cost of resolving all of the matters. The final cost may be materially higher than this provision. DOJ & State Subpoenas (1) / Risk Factor (2) FTC Investigation & Antitrust Litigation (1) ANDA Litigation & Inter Partes Review (1) (1) See 9 Mos. YTD 2017 Results Announcement published 11/2/17, pgs. 5 to 8 Litigation Update for complete description (2) See 9 Mos. YTD 2017 Results Announcement published 11/2/17 pgs. 8 to 9 Risk Factors for a complete description 37 Confidential: For Internal Use Only

38 The Facts: ANDA Litigation 1. Nothing has changed in the marketplace 2. ANDA filers must weigh the potential significant damages if launching at-risk 3 3. We are vigorously defending our IP: pursuing litigation for infringement of new 454 Orange Book listed patent issued in June Settled ANDA litigation with Mylan 5. Mylan terminated 514 and 497 IPR challenges; PTAB subsequently denied Dr. Reddy and Par s petitions to join the Mylan IPR since it was terminated 38

39 H Capital Markets Agenda Date Event Feb. 15 th Feb 27 th & 28 th FY 2017 Results (London Presentation) CSFB One-on-one Conference (London) March 12 th to 14 th Stifel-sponsored NDR (US) March 19 th Bank of America Merrill Lynch Bus Tour (London) May 2 nd Q Results (Conference Call) May 3 rd & 4 th Deutsche Bank US Healthcare Conference (Boston) June 5 th & 6 th Jefferies US Healthcare Conference (New York) 39